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Strawford A, Barbieri T, Van Loan M, et al. Resistance Exercise and Supraphysiologic Androgen Therapy in Eugonadal Men With HIV-Related Weight Loss: A Randomized Controlled Trial. JAMA. 1999;281(14):1282–1290. doi:10.1001/jama.281.14.1282
Author Affiliations: Department of Nutritional Sciences, University of California, Berkeley (Drs Strawford, Parks, Neese, Christiansen, and Hellerstein); Division of Endocrinology and Metabolism, Department of Medicine, San Francisco General Hospital, University of California, San Francisco (Drs Hellerstein and Christiansen); Western Human Nutrition Research Center, United States Department of Agriculture, Presidio of San Francisco (Ms Barbieri and Drs Van Loan and King); Human Nutrition Unit, London School of Hygiene and Tropical Medicine, London, England (Dr Strawford); Biotechnology General Corporation, Iselin, NJ (Dr Barton); and Department of Molecular and Medical Pharmacology, University of California, Los Angeles (Dr Catlin).
Context Repletion of lean body mass (LBM) that patients lose
in human immunodeficiency virus (HIV) infection has proved difficult.
In healthy, HIV-seronegative men, synergy between progressive
resistance exercise (PRE) and very high-dose testosterone therapy has
been reported for gains in LBM and muscle strength.
Objective To determine whether a moderately supraphysiologic
androgen regimen, including an anabolic steroid, would improve LBM and
strength gains of PRE in HIV-infected men with prior weight loss and
whether protease inhibitor antiretroviral therapy prevents lean tissue
Design Double-blind, randomized, placebo-controlled trial; post
hoc analysis for effect of HIV-protease inhibitor therapy conducted
from January to October 1997.
Setting Referral center in San Francisco, Calif.
Patients Volunteer sample of 24 eugonadal men with HIV-associated
weight loss (mean, 9% body weight loss), recruited from an AIDS clinic
and by referral and by advertisement.
Intervention For 8 weeks, all subjects received supervised PRE
with physiologic intramuscular testosterone replacement (100 mg/wk) to
suppress endogenous testosterone production. Randomization was between
an anabolic steroid, oxandrolone, 20 mg/d, and placebo.
Main Outcome Measures Lean body mass, nitrogen balance (10-day
metabolic ward measurements), body weight, muscle strength, and
Results Twenty-two subjects completed the study (11
per group). Both groups showed significant nitrogen retention and
increases in LBM, weight, and strength. The mean (SD) gains were
significantly greater in the oxandrolone group than in the placebo
group (5.6 [2.1] vs 3.8 [1.8] g of nitrogen per day
[P=.05]; 6.9 [1.7] vs 3.8 [2.9] kg of
LBM [P=.005];greater strength gains for
various upper and lower body muscle groups by maximum weight lifted
[P=.02-.05] and dynamometry
[P=.01-.05]). The mean (SD) high-density
lipoprotein cholesterol level declined 0.25 (0.14) mmol/L (9.8 [5.4]
mg/dL) significantly in the oxandrolone group
(P<.001 compared with placebo). Results were
similar whether or not patients were taking protease inhibitors. One
subject in the oxandrolone group discontinued the study because of
elevated liver function test results.
Conclusions A moderately supraphysiologic androgen regimen that
included an anabolic steroid, oxandrolone, substantially increased the
lean tissue accrual and strength gains from PRE, compared with
physiologic testosterone replacement alone, in eugonadal men with
HIV-associated weight loss. Protease inhibitors did not prevent lean
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